Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy

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Stony Brook University

Status and phase

Completed
Phase 4

Conditions

Laparoscopic Sleeve Gastrectomy
Post-operative Nausea and Vomiting

Treatments

Drug: Compazine
Drug: Dexamethasone
Drug: Aprepitant 80 mg Oral Capsule
Drug: Fentanyl
Drug: dexmedetomidine
Drug: Propofol
Drug: scopolamine transdermal
Drug: Reglan
Drug: Sevoflurane
Drug: Ondansetron
Procedure: Total intravenous anesthesia
Drug: Sugammadex
Drug: Desflurane

Study type

Interventional

Funder types

Other

Identifiers

NCT03435003
1074296-3

Details and patient eligibility

About

Bariatric surgery remains the most effective therapy for obesity. Postoperative nausea and vomiting (PONV) are commonly reported following bariatric surgery. The proposed study focuses on the most common bariatric procedure performed, laparoscopic sleeve gastrectomy (LSG), and aims to assess the effect of a post-operative nausea and vomiting-specific intervention. The investigators hypothesize that the intervention group will experience a reduction of nausea-related prolonged hospital stay and significantly improve patient-reported quality of recovery from surgery and quality of life.

Full description

To test this hypothesis, participants undergoing sleeve gastrectomy will be randomized to two groups: control vs Nausea specific-intervention group. All subjects will be assessed with a nausea specific questionnaire at 1, 4, 12, 24 hours and 3 weeks after surgery. Patient satisfaction with recovery will be assessed using specialized questionnaires at baseline, 24 hrs. and 3 weeks following surgery. Serial assessments of nausea, vomiting, quality of life and quality of recovery, will allow the investigators to identify an effect on incidence and severity of Post-operative Nausea and Vomiting. Importantly, the investigators will evaluate for an impact in patient-reported measures of quality of life. The total sample size is 83. This study will provide valuable insight on the epidemiology of post-operative nausea and vomiting after hospital discharge following Sleeve gastrectomy, which is currently poorly characterized. By allowing the investigators to assess the overall incidence of nausea and vomiting at different time points, this study will afford the opportunity to identify a time period of high incidence and further adjust our prevention efforts accordingly in future studies.

Enrollment

83 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adult patients (18 years and older) undergoing LSG

Exclusion criteria

  • Allergy to medications delineated in the protocol (muscle blockade, anesthetics, reversal agents)
  • Inability to provide informed consent
  • History of chronic nausea and emesis requiring medication
  • Poorly controlled diabetes (HgA1c>9 mg/dl),
  • History of previous bariatric or gastro-esophageal surgery

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

83 participants in 2 patient groups

Intervention Arm
Experimental group
Description:
A) Pre-operatively: aprepitant 80 mg oral capsule and scopolamine transdermal patch. B) Intra-operatively: total intravenous anesthesia (TIVA) will be maintained with IV infusions of propofol, and dexmedetomidine infusion or intermittent bolus dosing of fentanyl after induction. Sugammadex (2-4 mg/Kg IV) will be used for reversal of neuromuscular blockade in both groups. A single dose of dexamethasone 8 mg IV will be administered after induction, and a single dose of ondansetron 4 mg IV will be administered approximately 20 minutes prior to the end of operation. C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.
Treatment:
Drug: Sugammadex
Procedure: Total intravenous anesthesia
Drug: Ondansetron
Drug: Reglan
Drug: scopolamine transdermal
Drug: Propofol
Drug: dexmedetomidine
Drug: Fentanyl
Drug: Aprepitant 80 mg Oral Capsule
Drug: Compazine
Drug: Dexamethasone
Control Arm
Active Comparator group
Description:
A) Pre-operatively: No intervention B) Intra-operatively: inhalation anesthetics (sevoflurane or desflurane) and intermittent opioid boluses will be used for maintenance of anesthesia, as standard practice in the institution of the investigators and across the country. PONV prevention measures in the control group will be limited to dexamethasone 8 mg and ondansetron 4 mg. C) Post-operatively: Scheduled ondansetron and Raglan every 6 hours, using Compazine as a rescue medication.
Treatment:
Drug: Desflurane
Drug: Sugammadex
Drug: Ondansetron
Drug: Sevoflurane
Drug: Reglan
Drug: Compazine
Drug: Dexamethasone

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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